News Alert: The FDA Has Withdrawn Temporary Guidance for Alcohol-Based Hand Sanitizers
By SC Johnson Professional
The U.S. Food & Drug Administration (FDA) recently withdrew temporary guidance for alcohol-based hand sanitizers. This guidance was placed in March 2020 to outline temporary policies for manufacturers (who were not drug manufacturers) that began producing alcohol-based hand sanitizer during the COVID-19 public health emergency when supplies were short[1].
According to a media release from the FDA, “the supply of alcohol-based hand sanitizer from traditional suppliers has increased, and now, most consumers and healthcare personnel are no longer having difficulty obtaining these products. Therefore, we have determined it’s appropriate to withdraw the temporary guidance and are providing manufacturers time to adjust their business plans related to production of these products under these temporary policies.[2]”
What Does this Mean?
As of the new year, any company manufacturing hand sanitizers under the temporary guidance must now cease production. Those who would like to continue must comply with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practices (CGMPs) requirements. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidance can no longer be sold or distributed by manufacturers after March 31, 2022[3].
Continue to Check Ingredients and Product Labels
Given this change in policy, it is still important to continue to research the ingredients, product labels and safety statements on all hand sanitizer products. According to the Centers for Disease Control and Prevention (CDC), alcohol-based hand sanitizer must contain at least 60 percent alcohol to be effective[4]. The FDA also urges consumers not to use sanitizers that contain methanol, 1-propanol, benzene, acetaldehyde, or acetal[5].
All of SC Johnson Professional hand sanitizers and antimicrobial skin care products are listed with the FDA and are produced at FDA-registered facilities. The ethanol used in SC Johnson Professional hand sanitizers is US Pharmacopeia (USP) Grade and is denatured as an added safety feature, as required by the FDA monograph. The FDA-registered facilities comply with CGMPs and are inspected by the FDA. Learn more about SC Johnson Professional hand sanitizer solutions here: https://www.scjp.com/en-us/products/product-category/skin-care-6201/product-type/9596
For more tips to navigate hand hygiene ingredient lists and product labels, visit https://www.scjp.com/en-us/news/2021/infection-prevention-what-ingredients-are-your-hand-hygiene-products.
For more information about SC Johnson Professional products, visit www.scjp.com.
[1] https://www.fda.gov/news-events/press-announcements/fda-brief-fda-withdrawing-temporary-guidances-alcohol-based-hand-sanitizers
[2] https://www.fda.gov/news-events/press-announcements/fda-brief-fda-withdrawing-temporary-guidances-alcohol-based-hand-sanitizers
